- Oracle (Harrisburg, PA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible...5 years of relevant experience + 2+ years of medical device regulatory experience preferred… more
- Oracle (Harrisburg, PA)
- …and industry collaboration around AI in healthcare. Required Qualifications + 8+ years in medical device regulatory affairs or regulatory ... deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within...as a reviewer, regulatory scientist, or senior regulatory affairs leader. + Demonstrated experience reviewing… more
- Globus Medical, Inc. (Audubon, PA)
- …experience in medical device industry or equivalent, preferably within orthopedic medical devices ; Regulatory Affairs experience is a plus. + ... At Globus Medical , we move with a sense of urgency...lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting… more
- GRAIL (Harrisburg, PA)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… more
- Cardinal Health (Harrisburg, PA)
- …data analysis & regulatory requirements. + Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific ... develop high-quality clinical documents. Extensive knowledge of the European medical device guidelines/regulations such as MEDDEV and...and Medical Affairs , Clinical or Regulatory … more
- West Pharmaceutical Services (Exton, PA)
- …Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's Transfer Devices with an emphasis on gaining ... regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner...with 5+ years; Master's degree/PhD with 3+ years of medical device , pharmaceutical or regulatory … more
- Dentsply Sirona (York, PA)
- …Years and Type of Experience: + 5(+) years of experience in regulatory affairs , preferably in the medical device industry. + Experience with leading ... regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This...+ Experience with software as a medical device , AI and/or medical devices … more
- Globus Medical, Inc. (Audubon, PA)
- … device industry, or equivalent. + Minimum of 3 years' experience in a regulatory capacity within the medical device industry, or equivalent, preferably ... At Globus Medical , we move with a sense of urgency...as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs , is responsible for preparing, filing… more
- West Pharmaceutical Services (Exton, PA)
- …+ Bachelor's with 5+ years required; or + Master's degree/PhD 2+ years medical device regulatory experience required **Preferred Knowledge, Skills and ... Sr. Specialist, Regulatory Affairs , Product Stewardship Requisition ID:...legislations (eg California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global… more
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